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2 clusters · 2 sources · 7 days · First seen · Last updated
USFDA inspections of Dr. Reddy’s Laboratories plants
Overview
Dr. Reddy’s Laboratories has faced multiple USFDA regulatory observations following pre-approval inspections at its manufacturing facilities in Andhra Pradesh.
On October 8, 2026, the company reported receiving a USFDA Form 483 containing two observations after an inspection of its FTO-11 facility in Pydibhimavaram conducted between October 5 and October 7. The company stated it intends to address these observations within the regulator’s stipulated timeframe.
Following this, on October 15, 2026, it was reported that the USFDA issued a Form 483 with three observations after a pre-approval inspection at the FTO-9 facility in Visakhapatnam, which took place from October 8 to October 9. Dr. Reddy’s indicated it would provide a corrective response within the required timeline. These incidents follow previous observations at the company’s Pydibhimavaram and Srikakulam plants.
Entities
Andhra Pradesh · Dr. Reddy's Laboratories · USFDA · US Food and Drug Administration · Visakhapatnam
Timeline
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[BUSINESS] 2 sourcesDr. Reddy's receives three USFDA observations at Visakhapatnam plant
The USFDA issued three observations via a Form 483 following a pre-approval inspection at Dr. Reddy’s Laboratories’ FTO-9 facility in Visakhapatnam, India.
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[BUSINESS] 2 sourcesDr. Reddy's Laboratories receives USFDA observations at Andhra Pradesh plant
Dr. Reddy's Laboratories received two USFDA Form 483 observations following a pre-approval inspection at its FTO-11 manufacturing facility in Andhra Pradesh, India.
Sources
equitypandit.com · medicaldialogues.in